A SERVICE
ANNOUNCEMENT FROM:
  ACT

ExL Pharma Proudly Presents

2nd Quality Oversight of Clinical Vendors

Strategies for Assessing and Managing Quality at CROs and other Specialty Providers

October 17-19, 2011 | Westin Arlington Gateway | Arlington, VA

Agenda | Pricing | Venue | Faculty | Brochure | Register


Scroll Down for Choose from two pre-conference interactive workshops:

WORKSHOP A – ADVANCED VENDOR OVERSIGHT: QUALITY OVERSIGHT & QUALITY MANAGEMENT 

How to Develop, Implement and Execute an Effective, Risk-Based Vendor Quality Management Plan

Liz Wool,
CCRA, CMT, President & CEO,
QD-QUALITY AND TRAINING SOLUTIONS, INC.

Member, Board of Trustees, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS (ACRP) 


WORKSHOP B –
CLINICAL MONITORING

Strategies for Identifying, Overseeing and Administering New and Effective Clinical Monitoring Models  

Eileen DiRita,
GCP Compliance Manager, ENDO PHARMACEUTICALS

Richard Reeve,
Senior Director, QA, ENDO PHARMACEUTICALS

Sharon Reinhard,
Associate Director, Clinical QC, ENDO PHARMACEUTICALS

Attend the Conference to Receive a FREE Copy of the Executive Summary of Avoca Group's 2011 Survey on Reducing Micro-Management of CROs While Maintaining Effective Quality Oversight, Results from over 280 Sponsor & Service Providers.

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Join our LinkedIn group to network and interact with other GCP Professionals – Proactive GCP Compliance

The 2nd Quality Oversight of Clinical Vendors Conference is just around the corner, taking place October 17-19 at the Westin in Arlington, VA. Register now and join the almost 100 senior-level clinical quality and compliance professionals expected to attend including representatives from the following companies: 

ACM Global Central Laboratory

Acucela Inc

Advance Research Associates

Aeras

Agensys

AMAG Pharmaceuticals, Inc.

AstraZeneca

Beaufort LLC

Bristol-Myers Squibb

Celgene Corp.

Cephalon, Inc.

ClinAudits

Compliance Implementation Services

Cubist Pharmaceuticals, Inc.

Eli Lilly

Endo Pharmaceuticals

Endocyte

Falcon Group

Fibrogen

Forest Laboratories, Inc.

Hospira, Inc.

ICON Clinical Research

ImClone

Janssen Pharmaceutica NV

Johnson & Johnson

Johnson and Johnson Consumer and Personal Products Worldwide

Johnson and Johnson Consumer Products Worldwide

Kforce Clinical Research

Kyowa Hakko Kirin Pharma Inc.

LEO Pharma

Lung Rx

MacroGenics

Medtronic

Metrics Champion Consortium

Millennium Pharmaceuticals, Inc.

Mylan Pharmaceuticals Inc.

PharmaNet

PHT Corporation

POZEN Inc.

QD-Quality and Training Solutions, Inc.

Regeneron Pharmaceuticals Inc.

Regulatory Risk Management, LLC

ReSearch Pharmaceutical Services, Inc.

Roche

RPS

Shire

Takeda Global Research & Development Center, Inc.

The Avoca Group, Inc

The Weinberg Group

UCB Biosciences, Inc

ViroPharma Incorporated

Warner Chilcott

   

The expert speaking faculty present case studies, best practices and lessons learned from their experiences on such topics as:

  • CLINICAL MONITORING:  Case Study Examples of Clinical Monitoring Oversight from an Auditor's Perspective
  • QUALITY METRICS:  Defining, Implementing and Tracking Quality Metrics to Effectively Oversee Vendor Performance and Clinical Conduct 
  • COMMUNICATION OPTIMIZATION: Establishing Internal and External Communication Plans to Facilitate Effective Oversight 
  • QUALITY MANAGEMENT PLAN:  Sponsor-CRO Quality Management Plans: An Integrated Approach to Building Relationships, Increasing Transparency and Ensuring Quality
  • IN-PROCESS AUDIT STRATEGY:  Effectively Gauging a Vendor’s Performance and Verifying Compliance by Auditing Ongoing Work Streams 
  • VENDOR QUALIFICATION:  Strategies for Effective Risk Assessment when Selecting a Vendor
  • LEGAL PERSPECTIVE:  An Overview of Issued FDA Warning Letters: What Happened and What Can be Learned

 

Register Now!

Please Use Promo Code: P1311ACT

Questions?  Comments?  Contact Kristen Hunter at khunter@exlpharma.com

Sponsors & Exhibitors



PHT

Association Partners


ACRP   MCC
     
SCDM

For more information on the available sponsoring and exhibiting opportunities, please contact Mark Coulter at 917-258-5140 or mcoulter@exlpharma.com.


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+1 212.400.6240. info@exlpharma.com


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